A Randomized, Multicenter, Double-Blind, Placebo Controlled, Parallel Group Study of NT0102 in Children (Ages 6 to 12 Years) With Attention-Deficit Hyperactivity Disorder
Phase of Trial: Phase III
Latest Information Update: 19 Jun 2017
At a glance
- Drugs Methylphenidate (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Neos Therapeutics
- 19 Jun 2017 According to Neos Therapeutics media release, based on the results from this study the U.S. FDA approved Cotempla XR-ODT orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old.
- 19 Jun 2017 Results published in the Neos Therapeutics media release.
- 20 Dec 2016 According to Neos Therapeutics media release, the company has announced that it has completed the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Cotempla XR-ODT.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History